drug facts

drug facts
SPL v4
SPL
SPL Set ID 08922efa-5a90-4dfb-b9f4-a6c4f8dba3c9
Route
topical
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (0.005 g)
Inactive Ingredients
butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) cetyl alcohol cocamidopropyl betaine coconut acid distearyl phthalamic acid ethylhexylglycerin glycerin hydrogenated polybutene (1300 mw) lauric acid lauryl glucoside myristic acid phenoxyethanol phytosteryl/octyldodecyl lauroyl glutamate potassium cocoate potassium cocoyl glycinate potassium hydroxide propanediol propylene glycol d&c red no. 33 sodium chloride sodium cocoyl isethionate sodium isethionate sulfur titanium dioxide tocopherol d&c violet no. 2 water xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-03-10

Purpose

Acne treatment

Description

Salicylic Acid 0.5%


Medication Information

Warnings

For external use only

Uses

For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

Purpose

Acne treatment

Directions

Wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 30-60 seconds, avoiding all contact with eyes. Rinse thoroughly; pat dry. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water/Aqua/Eau, Cocamidopropyl Betaine, Potassium Cocoyl Glycinate, Glycerin, Sodium Cocoyl lsethionate, Lauryl Glucoside, Colloidal Sulfur, Potassium Cocoate, Cetyl Alcohol, Distearyl Phthalic Acid Amide, Hydrogenated Polyisobutene, Acrylates Copolymer, Propanediol, Myristic Acid, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Fragrance/Parfum, Sodium lsethionate, Xanthan Gum, Tocopherol, Coconut Acid, Lauric Acid, Potassium Hydroxide, Sodium Chloride, Ethylhexylglycerin, Propylene Glycol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool, Titanium Dioxide (Cl 77891), Ext. Violet 2 (Cl 60730), Red 33 (Cl 17200).

Description

Salicylic Acid 0.5%

Questions?

1-888-995-5656

Section 50565-1

Keep out of reach of children. If swallowed get medical help right away.

Active Ingredient

Salicylic Acid 0.5%

Stop and Ask A Doctor
  • If skin irritation occurs or gets worse.
When Using This Product
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Rinse right away with water if it gets in eyes.
Principal Display Panel – 125 Ml Tube Label

RODAN+FIELDS

UNBLEMISH

1

Refining Acne

Wash

Principal Display Panel – 125 Ml Carton Label

RODAN+FIELDS

UNBLEMISH

1

Refining Acne

Wash

RODAN+FIELDS

125 mL/4.2 Fl. Oz. U.S.


Structured Label Content

Warnings

For external use only

Uses

For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

Purpose

Acne treatment

Directions

Wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 30-60 seconds, avoiding all contact with eyes. Rinse thoroughly; pat dry. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water/Aqua/Eau, Cocamidopropyl Betaine, Potassium Cocoyl Glycinate, Glycerin, Sodium Cocoyl lsethionate, Lauryl Glucoside, Colloidal Sulfur, Potassium Cocoate, Cetyl Alcohol, Distearyl Phthalic Acid Amide, Hydrogenated Polyisobutene, Acrylates Copolymer, Propanediol, Myristic Acid, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Fragrance/Parfum, Sodium lsethionate, Xanthan Gum, Tocopherol, Coconut Acid, Lauric Acid, Potassium Hydroxide, Sodium Chloride, Ethylhexylglycerin, Propylene Glycol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool, Titanium Dioxide (Cl 77891), Ext. Violet 2 (Cl 60730), Red 33 (Cl 17200).

Questions?

1-888-995-5656

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help right away.

Active Ingredient (Active ingredient)

Salicylic Acid 0.5%

Stop and Ask A Doctor (Stop and ask a doctor)
  • If skin irritation occurs or gets worse.
When Using This Product (When using this product)
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Rinse right away with water if it gets in eyes.
Principal Display Panel – 125 Ml Tube Label (Principal Display Panel – 125 mL Tube Label)

RODAN+FIELDS

UNBLEMISH

1

Refining Acne

Wash

Principal Display Panel – 125 Ml Carton Label (Principal Display Panel – 125 mL Carton Label)

RODAN+FIELDS

UNBLEMISH

1

Refining Acne

Wash

RODAN+FIELDS

125 mL/4.2 Fl. Oz. U.S.


Advanced Ingredient Data


Raw Label Data

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